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A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46

Edwards Lifesciences LLC · Model 1151 · UDI-DI 00690103177701

DTJ Prescription
10
510(k) clearances
2
Adverse events
1
Recalls
13
Facilities

Description

RING HANDLE - EXTENDED 4"

Recalls

DateFirmReason
2002-04-30Carbomedics, IncExcessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.